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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > SG 1 Proposed Documents |
Title |
Description |
Posted Date |
Comments Due: |
Comments To: |
|---|---|---|---|---|
| SG1(PD)/N078R03 | Principles of Conformity Assessment for Medical Devices [Word] [PDF] [Additional Information] [Comments Template] |
5 October 2011 | 5 February 2012 | Nancy Shadeed or Alan Kent |
| SG1(PD)/N077R04 | Principles of Medical Devices Classification [Word] [PDF] [Additional Information] [Comments Template] | 5 October 2011 | 5 February 2012 | Nancy Shadeed or Alan Kent |
| SG1(PD)/N071R04 | Definition of the Term "Medical Device" [Word] [PDF] [Comments Template] | 28 March 2011 | 28 July 2011 | Nancy Shadeed or Alan Kent |
| SG1(PD)/N068R05 | Essential Principles of Safety and Performance of Medical Devices [Word] [PDF] [Summary of Changes] [Comments Template] | 28 March 2011 | 28 July 2011 | Nancy Shadeed or Alan Kent |
Updated 5 October 2011
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